Case Study:Children’s Chewable Tablet Product Fraud Investigation【Date:2017-12-14】


In 2016, the Food and Drug Administration developed the protocol for “Method for the determination of lutein and zeaxanthin in capsules” and initiated a special survey on the content of Lutein in commercially available lutein products.

The results showed that six products contained lutein content below the marked content. In particular, a Children’s chewable lutein tablet made by “Shih-Hung Pharmaceutical Co., Ltd” stood out with less than 80% of the labeling value of the product. Therefore, an official administrative audit was ordered and found that the company in question was suspected of replacing the original expiry date of products with a later date before repackaging them to be sold to customers again.This audit result was sent to the Yunlin District Prosecutors Office and a criminal investigation was immediately opened.

On May 11, 2016, Yunlin Prosecutor’s Office, the Police, the Investigation Bureau, Yunlin Health Bureau and Food and Drug Administration launched a joint investigation, interviewing the importers, manufacturers, distributors and subcontractors involved with the production of the concerned product and searched these operators’ offices and homes for evidence.

In this joint investigation, “Shih-Hung Pharmaceutical Co., Ltd” was found to have tampered with the lot number and expiry date of a total of 65 products. As a result, 25 million pills in the inventory were seized and a recall of products in the distribution and retail channels were ordered.

On July 12, 2016, Yunlin District Prosecutors Office officially indicted the relevant personnel for the violation of the Act Governing Food Sanitation and Fraud and seized the proceeds of illegal activities.


source: TFDA (